Cleared Traditional

ABBOTT TESTPACK(TM) D-DIMER (K890422) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890422 · Abbott Laboratories · Hematology device
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Mar 1989
Decision
60d
Days
Class 2
Risk

K890422 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) D-DIMER. Classified as Fibrin Split Products (product code GHH), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 27, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7320 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K890422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1989
Decision Date March 27, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHH Fibrin Split Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GHH Fibrin Split Products

All 10
Devices cleared under the same product code (GHH) and FDA review panel - the closest regulatory comparables to K890422.
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · Roche Diagnostics Corp. · May 2001
OPUS D-DIMER
K972316 · Behring Diagnostics, Inc. · Sep 1997
ABBOTT IMX(TM) D-DIMER
K893961 · Abbott Laboratories · Aug 1989
FIBRINOSTICON
K880077 · Organon Teknika Corp. · Feb 1988
DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET
K872360 · American Dade · Jul 1987
ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK
K852520 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1985